HDEC review and approvals

HDEC decision and approval process

Valid applications are assigned to an Health and Disability Ethics Committee (HDEC) for review. Learn more about the review process, what happens once approval is given and how to fill in the post-approval form.

Steps in the HDEC decision process

1. The application is checked for validity

Your application is checked for validity before being assigned for review.

Invalid applications

If your application is invalid (that is, either incomplete or outside the scope of HDEC review), we will advise you of this in writing.

Valid applications

Valid applications are assigned for HDEC review through one of these two pathways:

full review pathway

expedited review pathway.

If your application is valid, we will advise you in writing of the pathway by which it will be reviewed. If this is the full review pathway, we will also provide details of the relevant meeting, and invite you to attend in person or by phone.

2. HDEC review

The HDEC review process is set out in detail in the Standard Operating Procedures for Health and Disability Ethics Committees (SOPs): Read more about the SOPs for HDECs.

Full review pathway

Higher-risk applications are reviewed by the full review pathway. This means that a decision is made on the application at an HDEC meeting held in accordance with section 5 of the SOPs for HDECs. Final decisions on full review applications must be made within 35 days.

Expedited review pathway

Lower-risk applications are reviewed by the expedited review pathway. This means that a decision is made on the application between meetings, by a sub-committee of HDEC members, including the Chair. Final decisions on applications reviewed by the expedited review pathway, which is described in section 6 of the SOPs for HDECs, must be made within 15 days.

3. Decision made on your application

HDECs must make one of the following decisions on each application they review:

approve

provisionally approve

decline.

Definitions:

Approve:
This means that the HDEC is satisfied that your proposed research meets or exceeds established ethical standards.
Please note that HDEC approval alone is not usually sufficient to allow research to proceed. You may need to obtain other approvals (for example, from Medsafe, your university or polytechnic, or the localities where your research will be conducted) before you can start your study.

Provisionally approve:
This means that the HDEC requires changes to (or further information about) your research in order to be satisfied that it meets or exceeds established ethical standards. You have 90 days to make these changes or provide this further information. Each application may be provisionally approved only once.

Decline:
This means that the HDEC is not satisfied that your proposed research meets or exceeds established ethical standards. There are a number of options for challenging HDEC decisions to decline, which are set out in section 9 of the SOPs for HDECs. For more information about these options: Contact us

We will advise you in writing of the decision that has been made on your application.

What to do once you are given approval

You should usually commence your study within 12 months of HDEC approval. HDEC approval is automatically cancelled where a study has not commenced within 24 months.

Procedural rules around amendments and other post-approval items are contained in sections 11 and 12 of the SOPs for HDECs. These require researchers to:

obtain HDEC approval for all substantial amendments

submit annual progress reports

inform the HDEC of substantial protocol deviations or violations

notify the HDEC of the study’s conclusion or early termination

submit a final report.

Serious adverse events do not need to be individually reported to HDECs.